Drug: Viekira Pak (vee-KEE-rah-pak) and Viekira XR
Viekira Pak and Viekira XR is a combination of four drugs approved by the Food and Drug Administration (FDA) to treat chronic hepatitis C (Hep C or HCV) genotype 1. Viekira XR is a extended release formulation of Viekira Pak. Viekira should be taken with a meal. The drugs include:
- Ombitasvir(NS5A inhibitor)-taken twice a day
- Paritaprevir (protease inhibitor)/ritonavir (protease inhibitor)-taken once-a-day
- Dasabuvir taken twice daily (morning and evening)
Viekira is taken with and without ribavirin.
The overall cure rates of Viekira are 95% to 100%. The wholesale acquisition cost (WAC) for a 12-week treatment course of Viekira is $83,319. It is taken for 12 weeks based on the clinical trial data submitted to the FDA.
Patient Assistance Program: www.viekira.com/proceed-support 1-844-484-3547
Common Drug Interactions: The herb St. John’s wort should be avoided.Talk to your medical provider about any medications, supplements, herbs or over-the-counter medications you are taking to prevent any possible problems that may interfere with how well Viekira will work.
See the Highlights of Prescribing Information (Link) for a complete listing of drug interactions.
Note: The Food and Drug Administration (FDA) is requiring that hepatitis C (HCV) medication guides (package inserts) list a warning about a possible risk of hepatitis B (HBV) reactivation while on HCV antiviral therapy. Reactivation of HBV can cause possible liver damage. However, the risk is extremely rare. The reactivation has been reported with interferon and direct-acting antiviral medications.
Patients should talk to their medical providers about the hepatitis B tests and vaccination prior to starting HCV treatment.
Side Effects: The most common side effects of Viekira with ribavirin that occurred in more than 10% of patients included fatigue, nausea, pruritus (itching), other types of skin reactions, insomnia (sleep problems), and asthenia (feeling weak or lack of energy). The most common side effects of Viekira without ribavirin that occurred in more than 5% of patients included nausea, pruritus, and insomnia.
Pregnancy: There are no studies of Viekira in pregnant women. Ribavirin can cause birth defects and miscarriages. If you are a male taking ribavirin you and your female sexual partner must use two types of effective birth control. Your female sexual partner will have to take a pregnancy test before and during treatment and 6 months after treatment ends.If you are a female taking ribavirin you and your male sexual partner must use two types of effective birth control. You will also have to take a pregnancy test before, during and 6 months after treatment ends.
Pediatric Patients: Viekira is not approved to treat pediatric patients.
HIV/HCV Coinfection: The same dosage recommendation for people who are coinfected with HIV and hepatitis C (HCV) are as those who are monoinfected with HCV. Careful attention should be given to potential drug-drug interactions to HIV antiviral drugs. Ritonavir is also an HIV-1 protease inhibitor. People who are coinfected with HIV and hepatitis C should also be on an HIV regimen to prevent a potential “protease inhibitor drug resistance.”
Recommended Treatment Duration – Cure Rates
|Patient Characteristics||Medications /Duration||Cure Rates|
|Genotype 1a, without cirrhosis||Viekira/ribavirin for 12 weeks||94% to 100%|
|Genotype 1a, with compensated cirrhosis||Viekira/ribavirin for 24 weeks||93% to 100%|
|Genotype 1b, with or without compensated cirrhosis||Viekira for 12 weeks||100%|
The clinical trials included treatment-naive, and treatment experienced patients
Viekira Pak Highlights of Prescribing Information
Viekira XR Highlights of Prescribing Information
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